"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
(Generic versions may still be available.)
Esclim (estradiol transdermal system) is indicated in the following:
1. Treatment of moderate to severe vasomotor symptoms associated with menopause. There is no adequate evidence that estrogens are effective for nervous symptoms of depression that might occur during menopause, and they should not be used to treat these conditions.
2. Treatment of vulval and vaginal atrophy.
DOSAGE AND ADMINISTRATION
The adhesive side of the Esclim (estradiol transdermal) system should be placed on a clean, dry area of the skin on buttocks, femoral triangle (upper inner thigh), or upper arm, but Esclim (estradiol transdermal) should not be applied to the breasts or other parts of the body. The Esclim (estradiol transdermal) transdermal system should be replaced every 3 to 4 days (twice a week). The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the unlikely event that a system should fall off, the same system may be reapplied. If necessary, a new system may be applied. In either case, the original treatment schedule should be continued.
Initiation of Therapy
For the treatment of moderate to severe vasomotor symptoms, and vulval and vaginal atrophy associated with menopause, and of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, treatment is generally initiated with the Esclim (estradiol transdermal) 0.025 transdermal system applied to the skin twice weekly, but the initial selection of the dose should be based on the evaluation of the severity of the patient’s symptomatology and responsiveness to estrogen treatment. Depending upon the clinical response to treatment, the dosage can then be titrated up or down to individual needs. In order to use the lowest dosage necessary for the control of symptoms, decisions to increase dosage should not be made until after the first 2 or 3 weeks of therapy. Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.
In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with the Esclim estradiol transdermal system may be initiated at once.
In women who are currently taking oral estrogens, treatment with the Esclim estradiol transdermal system should be initiated 1 week after withdrawal of oral hormone replacement therapy, or sooner if menopausal symptoms reappear in less than 1 week.
Esclim (estradiol transdermal) may be given continuously in patients who do not have an intact uterus. In those patients with an intact uterus, Esclim (estradiol transdermal) may be given on a cyclic schedule (e.g., 3 weeks on drug followed by 1 week off drug).
Esclim™ estradiol transdermal system 0.025 mg/day
(Each 11 cm2 system contains 5 mg of estradiol USP)
Patient Pack of 8 systems . . . . . . . . . . . . . . . . . . . . . . .NDC 64248-310-01
Esclim™ estradiol transdermal system 0.0375 mg/day
(Each 16.5 cm2 system contains 7.5 mg of estradiol USP)
Patient Pack of 8 systems . . . . . . . . . . . . . . . . . . . . . . .NDC 64248-320-01
Esclim™ estradiol transdermal system 0.05 mg/day
(Each 22 cm2 system contains 10 mg of estradiol USP)
Patient Pack of 8 systems . . . . . . . . . . . . . . . . . . . . . . .NDC 64248-330-01
Esclim™ estradiol transdermal system 0.075 mg/day
(Each 33 cm2 system contains 15 mg of estradiol USP)
Patient Pack of 8 systems . . . . . . . . . . . . . . . . . . . . . . .NDC 64248-340-01
Esclim™ estradiol transdermal system 0.1 mg/day
(Each 44 cm2 system contains 20 mg of estradiol USP)
Patient Pack of 8 systems . . . . . . . . . . . . . . . . . . . . . . .NDC 64248-350-01
Store at 25°C (77°F); excursion permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Do not store unpouched. Apply immediately upon removal from the protective pouch.
Distributed by: WOMEN FIRST HEALTHCARE, INC. San Diego, CA 92130, Manufactured by: Laboratoires Fournier S.A. 21000 Dijon, France, Made In France July 1999, ©WFHC1999 PN0303
Last reviewed on RxList: 1/12/2005
This monograph has been modified to include the generic and brand name in many instances.
Additional Esclim Information
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